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Recruiting NCT07324980

Acute DYSPnea in the Emergency Department: Diagnostic Value of Point-of-care UltraSound

Trial Parameters

Condition Hydrostatic Pulmonary Edema
Sponsor Università degli Studi del Piemonte Orientale Amedeo Avogadro
Study Type OBSERVATIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-11-01
Completion 2028-11

Brief Summary

Acute dyspnea is a common reason for emergency department (ED) admission and is frequently caused by acute heart failure with pulmonary edema. Rapid differentiation between cardiogenic and non-cardiogenic causes of dyspnea is essential to guide early treatment and risk stratification. However, no single gold standard exists for the assessment of venous congestion in the acute setting. This prospective observational study aims to evaluate the diagnostic accuracy of respiratory variation in inferior vena cava (IVC) diameter measured by point-of-care ultrasound (POCUS) in identifying acute pulmonary edema in patients presenting to the ED with acute respiratory failure. In addition, the study investigates whether integration of IVC ultrasound with lung ultrasound, bedside cardiac ultrasound, and selected clinical and laboratory variables - such as hemoglobin and plasma protein changes - improves diagnostic performance and prognostic stratification.

Eligibility Criteria

Inclusion Criteria: * Adults aged ≥18 years. * Presentation to the emergency department with acute dyspnea and acute respiratory failure, defined by at least one of the following: * PaO₂ \< 60 mmHg on room air, or * Oxygen saturation (SpO₂) \< 90% on room air, or * PaO₂/FiO₂ ratio \< 300. * Ability to provide written informed consent or eligibility for deferred consent according to local regulations. * Undergoing standard diagnostic evaluation including laboratory tests and chest imaging as part of routine clinical care. Exclusion Criteria: * Refusal to provide informed consent (or consent by legal representative when applicable). * Inadequate ultrasound window or technically insufficient ultrasound assessment. * Acute respiratory failure secondary to chest trauma. * Cardiac arrest at presentation or during emergency department stabilization. * Requirement for invasive mechanical ventilation during initial stabilization in the emergency department.

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